MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1019137, medical device expiration date: 2023-12-31, device manufacture date: 2021-02-16.Medical device lot #: 1035833, medical device expiration date: 2024-01-31, device manufacture date: 2021-06-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: the plunger would only flush up to approx the 3 or 4ml line and would not advance.I have saved the three syringes that this happened with.Not sure if perhaps the syringes got too hot in transit to our home this summer that might cause this or if something happened prior to shipment.We used the flush initially not knowing there was a problem until it suddenly would not advance past the 3 or 4ml mark.

Event Description

It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: the plunger would only flush up to approx the 3 or 4ml line and would not advance.I have saved the three syringes that this happened with.Not sure if perhaps the syringes got too hot in transit to our home this summer that might cause this or if something happened prior to shipment.We used the flush initially not knowing there was a problem until it suddenly would not advance past the 3 or 4ml mark.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12447037
• MDR Text Key: 270551483
• Report Number: 1911916-2021-00962
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1